the Effect of Oral Vasopressors for Liberation From IV Vasopressors in Spinal Shock

October 7, 2020 updated by: Ahmed talaat ahmed aly

The Effect of Oral Midodrine Versus Oral Desmopressin Acetate Use for Liberation From IV Noradrenaline in Intensive Care Unit Patients Recovering From Spinal Shock .

the study is developed to evaluate the effect of use of oral vasopressors (midodrine versus minirin) on weaning ICU patients from IV vasopressors (noradrenaline) and compare between them for efficacy in shortage the duration of IV vasopressor and has low complications and side effects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of 18 - 60 years.
  • Patients of both genders.
  • Patients diagnosed by spinal shock and they are in the recovery stage .

Exclusion Criteria:

  • Patient refusal.
  • Anuric or oliguric patients or patients with chronic kidney disease.
  • Patients with allergy to medication included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: midodrine group
midodrine group will receive midodrine 10 mg PO q8hr with gradual weaning of IV noradrenaline after receiving 4 doses of oral midodrine
Drug: Midodrine Oral Tablet
midodrine group will receive midodrine 10 mg PO q 8 hr with gradual weaning of IV nor-adrenaline after receiving 4 doses of oral midodrine .
Experimental: minirin group
the patients will receive minirin 60 µg PO q8hr with gradual weaning of IV noradrenaline after receiving 4 doses of oral minirin
Drug: Minirin oral tablet
Minirin group will receive minirin 60 µg PO q 8 hr with gradual weaning of IV nor-adrenaline after receiving 4 doses of oral minirin .
Experimental: control group
the patients will receive IV nor-adrenaline and are gradually weaning from it according to routine hospital care without adding oral midodrine or oral minirin .
Drug: Nor-Adrenaline
control group will receive IV nor-adrenaline and is gradually weaning from it according to routine hospital care without adding oral midodrine or oral minirin .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
liberation the patient from IV vasopressors with maintaining hemodynamics.
Time Frame: 48 hrs
Blood pressure will be assessed regularly every 15 minutes
48 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmed talaat ahmed aly

Investigators

  • Principal Investigator: Ahmed T Ahmed, lecture, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 28, 2021

Study Registration Dates

First Submitted

October 7, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • oral vasopressors

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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